我院151例严重的药品不良反应报告分析.pdf

我院151例严重的药品不良反应报告分析 ＊ # 尚丹婷 ，李 洵，陈美玲，许惠英，朱红球（广东省人民医院/广东省医学科学院药学部，广州 510120） 中图分类号 R969.3；R978.1 文献标志码 A 文章编号 1001-0408（2015）11-1514-03 DOI 10.6039/j.issn. 1001-0408.2015.11.25 摘 要 目的：了解我院严重药品不良反应（ADR ）发生的特点及规律，为促进临床安全、合理用药提供参考。方法：对我院 2010－2013年上报的151例严重的ADR 报告进行统计、分析。结果：发生2例疑似ADR 死亡病例；男性和老年患者严重的ADR 发生率较高，分别占53.64％和44.37％；口服给药引起的严重的ADR 占47.68％，静脉给药占45.03％；在涉及的所有药品中，抗微 生物药和抗肿瘤药各占18.54％，循环系统药占14.57％；严重的ADR 累及器官/ 系统以血液系统最多，占22.16％。结论：临床应关 注严重的ADR 涉及药品及其引起机体损害的临床表现，加强用药监测，减轻或避免严重的ADR 的发生；药品生产企业应加强产 品上市后安全性研究及ADR 跟踪监测，完善产品说明书，增加相关安全性信息。 关键词 严重的不良反应；合理用药；死亡；老年患者 Analysis of 151Cases of Serious Adverse Drug Reaction Reports in Our Hospital SHANG Dan-ting ，LI Xun ，CHEN Mei-ling ，XU Hui-ying ，ZHU Hong-qiu （Dept. of Pharmacy ，Guangdong People ’s General Hospital/Guangdong Academy of Medical Sciences ，Guangzhou 510120，China ） ABSTRACT OBJECTIVE ：To explore the characteristics and regular patterns of serious adverse drug reactions （ADR ）and pro- vide reference for the safety drug use in clinic. METHODS ：151reports of serious ADR in our hospital from 2010to 2013were sta- tistically analysis. RESULTS ：2 cases were suspected as death ；the incidences of ADR in male and elderly patients were high ，ac- counting for 53.64％ and 44.37％，respectively ；serious ADR caused by oral and intravenous administration were respectively 47.68％and 45.03％. In all the involving drugs ，the ratio of anti-microbial drugs and anti-tumor drugs was 18.54％for both ，and the drugs of circulatory system was 14.57％. Blood system had large proportion and the most serious ADR involving organs or sys- tems （22.16％）. CONCLUSIONS ：Clinic should pay attention to the serious ADR drugs and their clinical manifestations ，strength- en drug monitoring ；It is suggested that the manufacturers should strengthen the safety research and ADR tracking and monitoring after t